The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2410-2015·Announced 2015-08-26

Teleflex Recalls Bronchial One Lumen Tubes Due to Connector Detachment

Teleflex is recalling Bronchial One Lumen Tubes because the cobb connector may detach from the main connector prior to use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Teleflex, Inc. is recalling Bronchial One Lumen Tube - Right devices. The recall is being conducted because customer complaints reported that the cobb connector detached from the main connector prior to use.

The affected products are identified by Product Code 115901-000065 and Product Code 115901-000080. Specific batch numbers are listed in the structured product information. The devices were distributed to various U.S. states, Puerto Rico, and several international locations including Canada, Bolivia, Ecuador, Hong Kong, Malaysia, the Philippines, Taiwan, and Trinidad & Tobago.

Healthcare providers and facilities should stop using the affected devices and contact Teleflex for further instructions on the recall process.

The recalled product

Product
Bronchial One Lumen Tube - Right
Manufacturer
Teleflex, Inc.
Category
Medical Device — Airway Management
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product Code 115901-000065 Batch Number 13FT06
  • 13IT05
  • 13JT08
  • 13KT12
  • 14CT11
  • 14DT03
  • 14DT24
  • 14ET04
  • 14FT04
  • 14FT20
  • 14GT10
  • Product Code 115901-000080 - Batch Number 13GT16
  • 13KT18
  • 13LT08
  • 14GT15
  • 14HT12
  • 14HT20
  • 14JT04
  • 14JT12
  • 14JT21

Distribution

Distributed in 40 states:

Part of a larger recall action

This product is one of 9 recalled by Teleflex, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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